Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization

This research is testing a new gene therapy called XC001. It’s for people who have serious heart problems, including ongoing chest pain (angina) and a weakened heart (left ventricular dysfunction), usually after a heart bypass operation. These patients are often at risk because their bypass surgery might not fully fix all their heart blockages. The study will compare XC001 to a placebo (a dummy treatment) to see if the gene therapy can make the heart work better and reduce symptoms like chest pain more effectively. Researchers will use special heart scans (CMR imaging) to measure changes over 26 weeks, with an optional extension period to look at effects over a full year. The goal is to find out if this new therapy can improve heart health in a meaningful way for these patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Xylocor Therapeutics Inc.

Enrolment target

Start

11 Nov 2025

Chronic angina and left ventricular dysfunction due to coronary artery disease that is considered high risk for incomplete revascularization via coronary artery bypass grafting

What is this study about?

This clinical trial is exploring a new treatment called XC001, which is a type of gene therapy. It's designed for people who have chronic angina (recurrent chest pain) and a weakened heart muscle, specifically a condition called left ventricular dysfunction. These conditions are usually caused by coronary artery disease, where the blood vessels supplying the heart become narrowed or blocked. Often, these patients have already had, or are about to have, a coronary artery bypass graft (CABG) surgery, which is an operation to improve blood flow to the heart. However, for some, the surgery might not be able to fix all the affected areas, leading to what doctors call 'incomplete revascularisation.'

The main idea behind this study is to see if XC001 can work alongside bypass surgery to improve heart health beyond what surgery alone can achieve. The researchers want to know if this gene therapy can help the heart function better and reduce the burden of heart problems. They will be comparing XC001 to a placebo, which looks like the real treatment but contains no active medicine. This allows them to see if any improvements are genuinely due to XC001 or if they would have happened anyway.

The study will last for 26 weeks, with a potential to extend for another 26 weeks, making it a year-long observation for some participants. During this time, the research team will use special imaging techniques (like MRI scans for the heart, called CMR imaging) to monitor changes in the treated parts of the heart. They'll be looking for improvements in how much blood flow the heart is getting and how well it's working. All these careful measurements will help them understand if XC001 is a safe and effective way to help people with these challenging heart conditions.

Key takeaways

New gene therapy (XC001) being tested for severe heart disease.
Aimed at people with ongoing chest pain and weakened heart after bypass surgery.
Compares XC001 to a dummy treatment (placebo).
Uses special heart scans (CMR) to check for improvements.
Study lasts 26 weeks, with a possible extension to 52 weeks.
Could offer new ways to improve heart health.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part.

To be included, you must have severe coronary artery disease, which means the blood vessels to your heart are significantly blocked. You'll also need to have ongoing chest pain, known as chronic angina, and your heart muscle must be weakened, a condition called left ventricular dysfunction. Importantly, your doctors must feel that even after a bypass operation, there's a good chance that not all the affected areas of your heart will get enough blood flow, meaning you are at risk for 'incomplete revascularization.'

There will be other detailed medical checks to make sure this study is right for you and safe. This includes reviewing your full medical history and current health status. The study team will discuss all the specific requirements with you to see if you meet the criteria to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic angina (chest pain)?
Do you have a weakened heart muscle (left ventricular dysfunction)?
Have you had or are you planning to have heart bypass surgery?
Has your doctor mentioned you are at risk for incomplete revascularization after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to either receive the new gene therapy, XC001, or a placebo (a dummy treatment). Neither you nor your study doctor will know which one you are receiving. Over 26 weeks, and potentially up to 52 weeks, you will have several visits to the clinic for assessments.

These assessments will include regular physical examinations, blood tests, and special heart scans called CMR imaging. These heart scans are very important to see how your heart is responding to the treatment. The first of these scans will happen a few days after your bypass surgery, and then again at 12 weeks, 26 weeks, and if you continue, at 52 weeks. You'll also be closely monitored for any changes in your symptoms or any side effects. All study-related medication and assessments will be provided at no cost, and you can withdraw from the study at any time.

Potential risks and benefits

Participating in this study might offer a potential benefit if you receive the active gene therapy, XC001, which could help improve your heart function and reduce your symptoms more effectively than standard care. However, as with any new treatment, there are potential risks, including side effects from the gene therapy or procedures involved. These will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
Germany
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Unverified
Hungary
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Unverified
Poland

Common questions

What is gene therapy?

Gene therapy is a new type of treatment that tries to fix problems by changing genes inside your body's cells. In this study, it aims to help your heart muscle work better.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers fairly compare the new treatment's effects.

What is CMR imaging?

CMR imaging is a special type of MRI scan that takes very detailed pictures of your heart. It helps doctors see how well your heart is working and how blood is flowing.

Will I still have my bypass surgery if I join this study?

Yes, this study is for people who have already had or are planning to have a heart bypass operation. The gene therapy is given as an 'add-on' treatment alongside your surgery.

How long will I be in the study?

The main part of the study lasts 26 weeks, but some people might be asked to continue for an extra 26 weeks, making it a full year.